How to check the compliance of subjects?

The drug packaging box sent to the subject will be returned to the investigator by the subject after the end of the trial. The subject should be emphasized to return all drug packaging, including the packaging of used up and remaining drugs. This can help researchers to count the actual situation of patients taking drugs. If the test drug is a tablet or capsule, it should be packaged in aluminum foil or weekly, so that when the package is returned to the investigator, the used up and remaining, missed or lost drugs and the date can be clearly displayed. If the tablet drugs are put into the bottle, count the remaining drugs after the drugs are returned to determine how many drugs are left, and then calculate how many drugs are taken by the patient. If it is a liquid drug, you should know how many drugs are in the bottle in advance. After the treatment, the volume of the remaining drugs was measured and the amount used by the patients was obtained. Sometimes it is difficult to measure the compliance of patients. For example, when drugs are packed in glass vials, the compliance can be measured by comparing the weight of containers before and after treatment. Another way to measure patient compliance is to detect the level of trial drugs in the subjects' blood samples. This can ensure that the subject took the trial drug and knew whether it reached the therapeutic level in the blood. As for the more accurate method of measuring compliance (especially in single dose trials), a small amount of non effective dye can be added to the trial drugs, and the patient's urine sample can be taken at each follow-up. Because the dye is discharged by the prototype and makes the urine fluorescent under UV light, this simple and fast method can be used to check whether there is dye in the urine. Of course, this method can only check the recent medication situation of patients and cannot determine the consistent compliance of patients. A microchip can also be installed in the drug bottle cap to record the date and time when the cap is opened each time. Although this method accurately records the time and date when the patient opened the drug bottle, it is not sure that the patient must have taken the trial drug. Carefully asking the subject about medication is another effective way to check compliance. Of course, no method of checking compliance is perfect. Usually, multiple methods are used at the same time to determine the compliance of subjects in the trial.